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Clinical Trials/NCT03777709
NCT03777709
Completed
N/A

The FAITH! Trial: A mHealth Intervention to Improve Cardiovascular Health Among African-Americans

Mayo Clinic1 site in 1 country85 target enrollmentFebruary 1, 2020

Overview

Phase
N/A
Intervention
Not specified
Conditions
Cardiovascular Diseases
Sponsor
Mayo Clinic
Enrollment
85
Locations
1
Primary Endpoint
Smoking Status Category
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

The purpose of this project is to apply a community-based participatory research (CBPR) approach to rigorously refine and test the feasibility and preliminary efficacy of an existing cardiovascular (CV) health and wellness digital application (app) prototype to improve CV health according to the American Heart Association Life's Simple 7 (LS7) framework among African-American (AA) adults within faith communities. The investigators hypothesize that the app-based intervention will be feasible and improve LS7 among AAs from baseline to 6-months post-intervention.

Registry
clinicaltrials.gov
Start Date
February 1, 2020
End Date
June 23, 2022
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

LaPrincess C. Brewer

Associate Professor of Medicine

Mayo Clinic

Eligibility Criteria

Inclusion Criteria

  • African American race/ethnicity
  • 18 years or older
  • Own a smart phone
  • Have basic Internet navigation skills
  • Have at least weekly Internet access (i.e. at home, church, or other public access)
  • Have an active email address
  • Intake of fruits/vegetables less than 5 servings a day
  • No engagement in regular physical activity
  • Able to engage in moderate physical activity
  • Exclusion criteria:

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Smoking Status Category

Time Frame: 6 Months post-intervention

Change in the categorical score (poor, intermediate, ideal) of the smoking status LS7 component from baseline to 6 months. Poor = Current Smoker, Intermediate = Former Smoker (\<1 year), Ideal = Never or Former (\>1 year).

Intervention Feasibility Measures - Participant Engagement With Tracking

Time Frame: 6 months post-intervention

Participant engagement with weekly diet/physical activity tracking measured by number of times participant engaged with the tracking feature at 6 months post-intervention

Blood Pressure Change

Time Frame: 6 months post-intervention

Change from baseline blood pressure at 6 month post-intervention. (average of 3 sitting readings of systolic and diastolic pressures)

Number of Participants With and Without Engagement With Sharing Board

Time Frame: Immediate post-intervention

Participant engagement with sharing board measured by number of posts per month by each participant at immediate post-intervention

Fasting Glucose (Fingerstick)

Time Frame: 6 months post-intervention

Change from baseline to 6 months post-intervention fasting glucose

Fasting Lipid Panel

Time Frame: 6 months post-intervention

Change in fasting lipid panel from baseline to 6 months post-interventio

BMI

Time Frame: 6 months post-intervention

Change from baseline BMI at 6 months post-intervention

Life's Simple 7 Composite Score Change

Time Frame: 6 months post-intervention

Change from baseline Life's Simple 7 Composite Score at 6 month post-intervention The Life's Simple 7 Composite Score is adapted from the American Heart Association standards based on health assessment data and is a composite of each component (average BP from 3 readings, fasting lipid panel and glucose, height, weight, self-reported cigarette smoking status, dietary quality, and physical activity patterns). Point values are assigned to each component: 2 points for ideal, 1 point for intermediate, 0 points for poor. The total sum allows for a continuous measure of cardiovascular health ranging from poor to ideal (0-14 points). The final score will be categorized as 0-6 (poor), 7-8 (intermediate), 9-14 (ideal).

Intervention Feasibility Measures - Participant Engagement With Sharing Board

Time Frame: Immediate post-intervention

Participant engagement with sharing board measured by the number of participants sharing at least one discussion board post during the intervention

Dietary Quality (According to American Heart Association Guidelines by the Validated, Culturally Appropriate, Delta Nutrition Intervention Food Frequency Questionnaire-FFQ)

Time Frame: 6 months post-intervention

Dietary quality was measured using a checklist of foods and beverages, self-reported by participants at baseline and 6 months post-intervention. Responses range from never to 2 or more times per day (responses: never, \< once/month, once/month, 2-3 times/month, 1 time/week, 2 times/week, 3-4 times/week, 5-6 times/week, 1 time/day, 2 or more times/day). Nutrient intake was estimated via a computer software, multiplying reported food frequency by nutrient content, following by comparison to AHA guidelines. Healthy diet score include 5 components: 1. fruits and vegetables, ≥4.5 cups/d 2. fish, 2 or more 3.5-oz servings/wk 3. fiber-rich whole grains (≥1.1 g fiber/10 g carbohydrate), 3 or more 1-oz-equivalent servings/d 4. sodium, ≤1500 mg/d 5. sugar-sweetened beverages, ≤450 kcal/wk. Each component equals 1 point, resulting in scores from 0 to 5, which are categorized as Poor (0-1), Intermediate (2-3), or Ideal (4-5). Higher scores indicated better dietary quality.

Intervention Feasibility Measures - App Usability

Time Frame: 6 months post-intervention

App usability assesses four domains (Impact, Perceived usefulness, Perceived ease of use, User control) using the Health Information Technology Usability Evaluation Scale (Health-ITUES) instrument. 20 items are assessed, each on a 5-point scale ranging from 1 (strongly disagree) to 5 (strongly agree). The overall Health-ITUES score was calculated as the mean of all 20 items, with each item being equally weighted. Possible total scores range from 1.0 (minimum) to 5.0 (maximum). A higher total sum indicates higher perceived usability of the technology measured at 6 months post-intervention.

Physical Activity Patterns (Minutes/Week of Moderate and Vigorous Intensity Physical Activity, Measured by the International Physical Activity Questionnaire-IPAQ)

Time Frame: 6 months post-intervention

Change from baseline to 6 months post-intervention in the total minutes per week that a participant engaged in moderate and vigorous intensity physical activity.

Intervention Feasibility Measures - Participant Engagement With Modules

Time Frame: Immediate post-intervention

App engagement as measured by the number of modules completed by the participants during the intervention. The number of participants who completed \<5 and ≥5 modules (out of 10) was calculated.

Secondary Outcomes

  • Diet Social Support(6 months post-intervention)
  • Physical Activity Self-Efficacy(6 months post-intervention)
  • Psychosocial Measures - Religiosity/Spirituality(6 months post-intervention)
  • Psychosocial Measures - Optimism(6 months post-intervention)
  • Diet Self-Regulation(6 months post-intervention)
  • Physical Activity Social Support(6 months post-intervention)
  • Psychosocial Measures - Perceived Stress(6 months post-intervention)
  • Smoking at Baseline as Assessed by Cigarette Smoking Status(Day 1)
  • Diet Self-Efficacy(6 months post-intervention)
  • Physical Activity Self-Regulation(6 months post-intervention)

Study Sites (1)

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